TR-CICR (KEK) – Repealed
REGULATION ON THE INVENTORY AND CONTROL OF CHEMICALS
A Regulation on the Inventory and Control of Chemicals (“the Inventory Regulation”) was adopted and entered into force on 26 December 2008 in Turkey. The Inventory Regulation aims at gathering information and controlling risks on new and existing substances. The main mechanism to achieve this objective is through an obligation to notify certain information to the national chemical inventory. The Notifications were due March 31, 2011. This regulatin repealed after TURKREACH KKDIK is published.
Scope of the Inventory Regulation
The Inventory Regulation applies to most substances and preparations.
The Inventory Regulation has a very large scope in it that covers the manufacture, import, placing on market and use of both new and existing chemical substances either on their own or in preparations. Note that it applies to all substances and preparations, whether hazardous or not, with very few exceptions. The main exemptions are:
- A list of substances enumerated in the Annex I which corresponds to the list of substances in Annex IV of REACH which are exempted under article 2(7)(a) as "sufficient information is known about these substances that they are considered to cause minimum risk before of their intrinsic properties".
- The following substances which occur in nature, if they are not chemically modified: minerals, ores, ore concentrates, cement clinker, natural gas, liquefied petroleum gas, natural gas condensate, process gases and components thereof, crude oil, coal, coke.
- Basic elemental substances for which hazards and risks are already well known: hydrogen, oxygen, noble gases (argon, helium, neon, xenon), nitrogen.
- Polymers
- Articles
- Non-isolated Intermediates
- Food and Medical Devices
- Substances manufactured or imported in quantities below 1t/year
- Substance in custom transit (unless they are modified/processed)
- Substances for use in the military
Notification to the inventory
The main obligation set forth by the Inventory Regulation is the notification of certain information to the inventory of chemicals. The information requirements vary depending on the tonnages of the substance. Note that the notification to the inventory is free of charge.
Obligation to notify information to the inventory
1. Scope of the obligation
A very important aspect of the Inventory Regulation is that the obligation to notify only applies to Turkish based operators, either manufactures or importers. That is to say that the notifying importer has to be a Turkish legal entity. As a result, for non-Turkish operators importing in Turkey, information needs to be submitted either through its affiliate (in case it has one), through its Turkish customers, or through a Turkish Trustee.
The Trustee provision helps non-Turkish manufacturers preserve confidentiality. Otherwise, where a non-Turkish operator does not have an affiliate in Turkey, it will have to secure its relationship with its Turkish customers through contractual confidentiality agreements.
2. Reporting thresholds and information requirements
The information requirements vary upon the tonnage of substance imported or manufactured in Turkey. The Inventory Regulation provides for two different tonnage bands: from 1 to 1000 tonnes and above 1000 tonnes/year per operator.
Notifications need to be updated every three years.
Information Requirements
For substances manufactured or imported in quantities between 1t and 1000t/year or within three years preceding the entry into force of the Inventory Regulation, the information requirements are limited. More specifically, the following information shall be submitted to the inventory:
- Name, EC Number and CAS Number of the Substance,
- Quantity of the substance produced or imported,
- Classification of Substances including danger class, danger symbol, risk phrases and safety phrases,
- Information of the substance on prescribed areas of use.
Information requirements for substances manufactured or imported in quantities above 1000 tonnes/year per operator.
For substances manufactured or imported in quantities above 1000t/year or within three years preceding entry into force of the Inventory Regulation, the information requirements are the following
- Name, EC Number and CAS Number of the Substance,
- Quantity of the substance produced or imported,
- Classification of Substances including danger class, danger symbol, risk phrases and safety phrases,
- Information of the substance on prescribed areas of use,
- Data on physicochemical characteristics of the substance,
- Data on the behaviour and attitude of the substance among environmental media,
- Data on the ecotoxicity of the substance,
- Data on acute and subacute toxicity of the substance,
- Data on the carcinogenic, mutagenic effect of the substance and/or toxic effect on the reproductive system thereof,
- Other related information that may be used in risk assessment of the substance.
Note that in both cases, additional information may be required by the authorities.
Practical implementation of the obligation to notify information to the inventory
1. Notification deadline
Initially, the deadline provided in the Inventory Regulation was 26 December 2009. However, in view of the very short time span given to operators to comply with their obligations, the authorities officially extended the deadline to the 30 June 2010 and then again to 31 March 2011.
2. Notification in practice
The inventory is available on the website of the Ministry of Environment and Urbanisation. Note that it is only available in Turkish and will never be available in other languages because the Regulation only applies to Turkish operators.
In order to be able to notify information to the Inventory, the operator needs to first create an account by applying to the Ministry in order to obtain a login and password. Note that as said above, only Turkish legal entities can create an account.
Once the account is created, the notifier needs to fulfill the information relevant for its tonnage band. Note that where the information is not available, the notifier can leave the relevant space blank in the notification and explain to the authorities why the information is not applicable or available to it.
3. Joint submission of information
Article 10 provides for a possibility to rely upon information already submitted by an operator of the same substance in case of several manufacturers/importers of the same substance. In that case, the operators of that same substance need to enter into agreement whereby one producer or importer submits some information in the name of the others.
Note that only the following information may be submitted jointly:
- physicochemical and environmental data.
- ecotoxicity, acute and subacute toxicity data.
- Data on the carcinogenic, mutagenic effect of the substance and/or toxic effect on the reproductive system thereof,
- Other related information that may be used in risk assessment of the substance.
In case of joint submission, the following information must still be submitted individually:
- Information on the identity of the substance (Name, EC Number and CAS Number)
- Information on the company submitting the information.
- Quantity of the substance produced or imported.
- Information on the classification of Substances including danger class, danger symbol
- Information on areas of use of the substance.
In such cases, the operator relying upon another’s information shall, in its notification, make reference to the manufacturer/importer who has submitted the information:
4. Obligation to update information
Article 11 requires operators to provide an update of their notification in case of:
- New use which impacts the human or environmental exposure of the substance.
- New information on risk assessment, physicochemical, toxicological or ecotoxicological properties of the substance.
- Change in the classification.
- New information related to the risk posed by the substance to the environment or human health.
- Change in the tonnage band.
- Such update shall be performed within a month of the change and needs to be carried out on the internet, following the similar procedure than for the first notification. Note that update of information is free.
5. What Needs to Be Done
Feel free to Contact for information on how Doruk Sistem can assist you in fulfilling this obligation, specifically with respect to:
- Identifying a reliable Turkish OR
- Clarification of Exemptions from Notification
- Data entry in HEADSET